Evaluation of the Efficacy of Pulmonary Vein Isolation by Pulsed-field Ablation in Persistent Atrial Fibrillation: a Multicenter Study With Follow-up by Implantable Cardiac Monitor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the 12 month-efficacy (absence of atrial arrhythmias recurrences based upon ICM follow-up) after PVI using PFA in patients with persistent AF.
研究概览
简要总结
Atrial fibrillation (AF) is the most common sustained arrhythmia in adult population. According to current guidelines for the management of AF, radiofrequency (RF) ablation (including at least pulmonary vein isolation [PVI]) is a validated therapeutic option for persistent AF. Recently, Pulsed-field ablation (PFA) - a new non-thermal energy - has been used to treat paroxysmal and persistent AF with a high success rate in observational studies. This new technology is based on tissue-specificity on myocardium, avoiding collateral damages on adjacent structures. Before confirming a superiority of PFA over existing thermal energies, prospective studies concerning an exclusive population of persistent AF patients are needed, with rigorous assessment of the recurrences using continuous monitoring (insertable cardiac monitor [ICM]). PFA efficacy using ICM has never been evaluated. Before considering PFA in therapeutic strategies through large-scale randomized studies using rigorous monitoring of recurrences, preliminary studies are needed in a persistent AF population-only. This pilot cohort study will provide solid data of PFA efficacy (using continuous monitoring of recurrences) for future randomized studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic persistent AF (continuous episode sustained beyond 7 days)
- •Refractory, intolerant or unwilling to take ADT
- •Signed informed consent
- •Affiliation to medical social coverage.
- •Non inclusion Criteria:
- •Persistent long-term atrial fibrillation with ongoing episode continuous for more than 3 years;
- •Left ventricular ejection fraction ≤ 15% ;
- •Stage IV of the New York Heart Association classification;
- •Previous atrial ablation outside the cavotricuspid isthmus;
- •Wearer of an implantable electronic cardiac prosthesis (pacemaker or defibrillator; MCI)
- •Hypertrophic heart disease other than hypertensive hypertrophic heart disease;
- •Severe valvular heart disease, including the presence of a mechanical mitral valve or any mitral surgery;
- •Congenital heart disease, including atrial septal defect, patent foramen ovale treated by percutaneous closure with atrial septal prosthesis;
- •Presence of cardiac thrombus;
- •Myocardial infarction or percutaneous coronary angioplasty within the last 6 months;
- •Cardiac surgery within the last 6 months;
- •Systemic thromboembolic event less than 6 months ago;
- •Pulmonary embolism less than 6 months ago or pulmonary hypertension requiring specific treatment;
- •Inability to read independently
- •Vulnerable patient: minor, patient under curatorship or guardianship
排除标准
- 未提供
研究组 & 干预措施
Symptomatic persistent atrial fibrillation
干预措施: Persistent atrial fibrillation ablation using Pulsed-field ablation (Procedure)
结局指标
主要结局
To assess the 12 month-efficacy (absence of atrial arrhythmias recurrences based upon ICM follow-up) after PVI using PFA in patients with persistent AF.
时间窗: 12 months
Efficacy will be assessed by the absence of AF/AT (episodes \> 2min) recurrences during a 12-month follow-up period (clinical success) based upon continuous monitoring (ICM). Recurrence will be defined as any AF/AT episode \> 2 min (detected by ICM) after the 2-month blanking period.
次要结局
- Quantify the total atrial arrhythmias burden (AF/AT) over a 12-months period(12 months)
- Assess patient distribution according to residual arrhythmias burden after one year(12 months)